MAUDE Adverse Event Report: VANTIVE US HEALTHCARE LLC HOMECHOICE APD SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	5C4469C
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name:(b)(6).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that there was a foreign object inside the tubing of the homechoice cassette.This was identified during use of the device for peritoneal dialysis therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to h6 and h11: h11: the device was received for evaluation.A visual inspection with the naked eye showed a black, round partially encapsulated particulate matter inside the last fill line tubing.The reported condition was verified.The particulate matter was determined to be intrinsic to the manufacturing process, identified as pin buildup of burnt plastic material broken off during manufacturing (tubing extrusion process).The cause of the particulate matter was determined to be a manufacturing related issue during the extrusion process.A capa has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE APD SET
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): VANTIVE US HEALTHCARE LLC; deerfield IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - MOUNTAIN HOME; 1900 north highway 201; mountain home AR 72653
• Manufacturer Contact: 510 lake cook rd; deerfield, il, IL 60015 ; 8153072966
• MDR Report Key: 24332025
• Report Number: 2314912-2026-00100
• Device Sequence Number: 11981069
• Product Code: FKX
• UDI-Device Identifier: 07332414208479
• UDI-Public: 7332414208479
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K923065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 5C4469C
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown